# K143214: SCARLET® AC-T Secured Anterior Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Feb 23, 2015 after 105 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K841189 (1984). 112 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141314: Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation, Spineart (2014) Summary page 4.
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 4.
- K111439: Chesapeake (Cervical Components), K2m, Inc. (2011) Summary page 4.
- K112459: Synthes Zero-P, Synthes Spine Co.Lp (2011) Summary page 4.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.

## Most influential descendants
- K172065: Scarlet AC-T (2017), 2 descendants of its own
- K190322: SCARLET® AC-T Secured Anterior Cervical Cage (2019), 1 descendant of its own
- K240699: SCARLET® AC-Ti (2024), 0 descendants of its own

## Indications for use
The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Source page: https://510kreport.com/device/K143214
Methodology: https://510kreport.com/methodology